The investigators hypothesized that with the administration of the nutritional supplement Ocoxin-Viusid® is expected to improve the quality of life and enhance tolerance to chemotherapy in at least 70% of patients diagnosed with advanced pancreatic adenocarcinoma, treated at the "Hermanos Ameijeiras" Surgical Clinical Hospital. Phase II clinical trial, open, multicenter, nonrandomized.
To assess the effect of Ocoxin-Viusid® on the quality of life of patients with advanced pancreatic adenocarcinoma. To evaluate the effect of Ocoxin-Viusid® on the quality of life of patients. To evaluate the influence of Ocoxin-Viusid® on tolerance to onco-specific therapy. Identify the changes that occur in the nutritional status of patients receiving the supplement. To evaluate the toxicity of Ocoxin-Viusid® in combination with chemotherapy in patients with advanced pancreatic adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
An oral solution of Ocoxin-Viusid® (30 ml vials) will be used at a rate of 60 ml daily (1 vial every 12 hours), preferably administered after breakfast and lunch. It will be prescribed for a period of 2 weeks before starting the QT. The treatment with Ocoxin-Viusid® will continue in the possible periods of time of suspension of the chemotherapy treatment due to toxicities attributable to the oncospecific treatment. The treatment will be administered continuously from the inclusion of the patient in the study, up to one year.
"Hermanos Ameijeiras" Surgical Clinical Hospital
La Habana, Cuba
Quality of Life: EORTC QLQ-C30
Life quality measurement through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (ORTC QLQ-C30): an integrated system for assessing the healthrelated quality of life (QoL) of cancer patients participating in international clinical trials. It's composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Time frame: 12 months
Nutritional Status of the patient during Chemotherapy
Variations in the patient's nutritional status will be considered, measured by body mass Index (a measure of body fat based on height and weight that applies to adult men and women)
Time frame: 12 months
Adverse Events-AE during Chemotherapy Test
A test with the following questions: Occurrence of an AE in the subject \[Yes, No\]; Description of the AE \[Name of the event\]; Duration of the AE \[Difference between the start and end date of the event\]; Intensity of the AE \[According to CTCAE version 4 it will classify in Light, Moderate, Severe, Life-threatening consequences, Death related to AE\]; Seriousness of the AE \[serious or not serious\], Attitude with respect to the treatment under study \[No changes, dose modification, temporary or definitive interruption of the study treatment\], Result of the AE \[recovered, improved, persisted or sequelae\], Causal relationship \[According to WHO algorithm it will classify in very probable, probable, possible, improbable, unrelated, not evaluable\]
Time frame: 12 months
Hematology test
Levels of Hemoglobin, Platelets, Hemogram with differential in blood extractions.
Time frame: 12 months
Blood Chemistry test
Measure levels of GPT, GOT, Creatinine, Glycemia, Bilirrubin, Alkaline Phosphatase, LDH in blood.
Time frame: 12 months
Compliance with the treatment with chemotherapy (CT) and Immunotherapy (IT) test
Test with the next parameters: if the administration of chemotherapy (CT) and Immunotherapy (IT) treatments will be considered at planned time, number of the cycle administered out of date, days elapsed since the previous cycle and, cause that caused the administration of the CT/IT outside the planned date. In the case of the dose, the medication in which it was modified will be taken into account, as well as the modified dose.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.